OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease

This study has been completed.
Information provided by (Responsible Party):
Sabine Steiner, Medical University of Vienna Identifier:
First received: May 9, 2011
Last updated: August 24, 2014
Last verified: August 2014

The principal aim of the study is to determine the effects n3-PUFA on top of standard therapy on surrogate markers of disease severity and/or prognosis in patients with PAD.

Treatment duration will be 3 months, final follow-up is planned at 6 months after inclusion.

Primary outcome parameter is endothelial function assessed by flow-mediated vasodilation using brachial artery ultrasound.

Secondary outcome measures comprise maximum and pain-free treadmill walking distance, pulse wave velocity, whole blood viscosity, platelet activation and plasma markers of inflammation.

Condition Intervention Phase
Peripheral Arterial Disease
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • change from baseline endothelial function to 3 months [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    measured by flow mediated vasodilation

Secondary Outcome Measures:
  • change from baseline endothelial function to six months [ Time Frame: baseline, 6 months (3 months after treatment cessation) ] [ Designated as safety issue: No ]
  • change of walking distance (maximum/pain-free)from baseline to three months and six months [ Time Frame: baseline, 3, 6 months ] [ Designated as safety issue: No ]
  • change of inflammatory markers from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ] [ Designated as safety issue: No ]
  • change of pulse wave velocity from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ] [ Designated as safety issue: No ]
  • bleeding events [ Time Frame: 1, 3, 6 months ] [ Designated as safety issue: Yes ]
  • liver enzymes changes [ Time Frame: baseline, 1,3,6 months ] [ Designated as safety issue: Yes ]
  • change of platelet activation from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: January 2011
Study Completion Date: March 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omacor Drug: OMACOR
4 capsules OMACOR 1g per day
Placebo Comparator: Placebo Drug: Placebo
4 capsules placebo per day


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Severity of disease: Rutherford category II or III - moderate to severe Stable intermittent claudication
  • Ankle Brachial Index<0.9
  • Age ≥18 years
  • Adequate PAD therapy according to current AHA guidelines

Exclusion Criteria:

  • Current treatment with Omacor or other fish oil products
  • Planned vascular intervention
  • Known hypersensitivity to the study drug
  • Rest pain or ischemic ulcer
  • Exercise tolerance limited by factors other than PAD
  • Inability to perform treadmill test
  • Dual antiplatelet therapy (aspirin and clopidogrel)
  • Previous myocardial infarction
  • Known liver diseases, except fatty liver
  • Known bleeding diathesis
  • Women of childbearing potential who do not practice a safe contraception method
  • Current participation in another intervention study.
  • Previous participation in another study with an intervention within the last 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01367145

Medical University of Vienna, Department of Internal Medicine II, Division of Angiology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Sabine Steiner, Dr. Medical University of Vienna
  More Information

No publications provided

Responsible Party: Sabine Steiner, Prof., Medical University of Vienna Identifier: NCT01367145     History of Changes
Other Study ID Numbers: OMACOR II - 2011
Study First Received: May 9, 2011
Last Updated: August 24, 2014
Health Authority: Austria: Ethikkommission
Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
OMEGA-3 polyunsaturated fatty-acids
Peripheral Arterial Disease
Endothelial Function
Platelet Function

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on October 08, 2015